Kornimate/medical-research-clean huggingface dataset:
cardiomems hf system ous post market study

Conditions: Heart Failure; Left-Sided Heart Failure; Congestive Heart Failure

Summary: the purpose of this post market study (pms) is to evaluate the use of the cardiomems hf system in patients with new york heart association (nyha) class iii heart failure in a commercial setting.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from subject 2. ≥ 18 years of age 3. diagnosis of nyha class iii heart failure 4. at least 1 hf hospitalization within 12 months of baseline visit 5. subjects with reduced lvef heart failure should be receiving a beta blocker for 3 months and an ace-i or arb for one month unless in the investigator's opinion, the subject is intolerant to beta blockers, ace-i or arb. 6. subjects with a bmi ≤ 35. subjects with bmi \>35 will require their chest circumference to be measured at the axillary level, if \> 65 inches the patient will not be eligible for the study. 7. subjects with pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the rhc) 8. subjects willing and able to comply with the follow-up requirements of the study exclusion criteria: 1. subjects with an active infection 2. subjects with history of recurrent (\> 1) pulmonary embolism or deep vein thrombosis 3. subjects who, in the investigator's opinion, are unable to tolerate a right heart catheterization 4. subjects who have had a major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within 2 months of baseline visit 5. subjects with cardiac resynchronization device (crt) implanted \< 3 months prior to enrollment 6. subjects with a glomerular filtration rate (gfr) \< 25 ml/min (obtained within 2 weeks of the baseline visit) who are non-responsive to diuretic therapy or who are on chronic renal dialysis 7. subjects with congenital heart disease or mechanical right heart valve(s) 8. subjects likely to undergo heart transplantation or vad within 6 months of baseline visit 9. subjects with known coagulation disorders 10. subjects with a hypersensitivity or allergy to aspirin, and/or clopidogrel (not applicable for subjects taking anti-coagulation therapy or other approved anti-platelets therapy).
adolescent depression associated with parental depression

Conditions: Depression

Summary: depression is difficult to identify, prevent and treat in adolescents because of complex and stigmatized multiform symptoms and pathways of care. in children the existence of a parental depression is a significant and recognized risk factor for the development of a depression. it is regularly reported that 30% of adolescents of depressed parents have depression themselves. general practitioners (gp) have significant access to the depression of adults, potentially parents of teenagers. in fact, 20% of patients in the regular active file of one gp have depression. the primary health care system could provide indirect but voluminous and unprecedented access to the identification of adolescent depression at an early stage from the encounter of depressed parents. the difficulties of articulation between primary care (pc) and mental health devices are demonstrated. they disrupt the care pathways of adolescents detected in pc, prevention, and may even disturb early detection of depression. an organized joint between the pc and a specialized mental health service for adolescents ("maison des adolescents" mda) could promote the process of screening and preventing depression of adolescents of depressed parents encountered in pc. in addition, if the effects of parental depression on adolescents are established, they remain complex and interactive. they vary by age and sex of the child but also the sex of the parent. a concomitant study of adolescent and parent depression will provide data to analyze the prevalence of depressed parent adolescent depression and to define risk or protection factors. adodesp study is a cluster randomised trial (randomisation of the gps) which compare a group of adolescent with pc articulated with mental health service (mda) and an other group without articulation (routine cares). a third group of depressed adolescents will be constituted to analyse parental depression of depressed adolescents.


Eligibility criteria:
inclusion criteria: * parents of groups 1 and 2 : * major patient consulting his gp * depressed patient * parent of adolescent aged between 11 and 18 years old * adolescents of groups 1 and 2 : * aged more than 11 and less than 18 years old * parent included in the study * parents of group 3 : * parent of depressed adolescent under care at the mda of marseille, included in the study and whose depression is confirmed by hscl25 scale * adolescents of group 3 : * aged more than 11 and less than 18 years old * depressed patient * under care at the mda of marseille since less than 1 month exclusion criteria: * parents of groups 1, 2 and 3 : * minor patient * enable to give his consent * patient with guardianship or curatorship * non consenting patient * pregnant or nursing mother * adolescents of groups 1 and 2 : * aged \< 11 or ≥18 * parent whose depression isn't confirmed by hscl25 scale * non consenting adolescent * pregnant or nursing mother * adolescent of group 3 : * aged \< 11 or ≥18 * non depressed adolescent * non consenting patient * pregnant or nursing mother
a new paradigm for illness monitoring and relapse prevention in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this study was a 2-arm randomized control trial (rct) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. the rct compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.


Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders iv (dsm-iv) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis * 18 years or older * an inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry * willing and able to provide informed consent exclusion criteria: * hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening) * 6th grade reading level (determined by wide range achievement test- 4th edition)

Keywords: schizophrenia schizoaffective disorder mobile application relapse smi ehealth e-health health technology mhealth m-health mobile health serious mental illness electronic health
phrenic nerve mapping and stimulation ep catheter study: ping-ep study

Conditions: Heart Failure

Summary: the ping-ep study is designed to evaluate electrode properties on phrenic nerve stimulation (pns) in coronary sinus using a commercially available diagnostic electrophysiology catheter.


Eligibility criteria:
inclusion criteria: * subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (crt-p/crt-d) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (icd) or for system revision requiring repositioning of the transvenous left ventricular (lv) lead * patient has signed and dated the study-specific patient informed consent form * subject is at least 18 years of age exclusion criteria: * patient has a previous lv lead implanted not requiring repositioning * pregnant woman * patient is enrolled or planning to participate in any concurrent study, which would confound the results of this trial as determined by medtronic, during the course of this clinical study
budesonide/formoterol for maintenance and reliever therapy among asthma patients in thailand

Conditions: Asthma

Summary: the purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of budesonide/formoterol for maintenance and reliever therapy in usual-care setting.


Eligibility criteria:
inclusion criteria: * established persistent asthma * currently treated with symbicort smart for 3 months or longer exclusion criteria: * currently participating or have participated in a study with an investigational compound within the last 30 days * current diagnosis of chronic obstructive pulmonary disease (copd) * smoked more than 10 pack-year

Keywords: asthma symbicort smart thai patient eligibility persistent asthma
neuropathic pain in elderly people with diabetes: impact on quality of life and cognition

Conditions: Diabetes Mellitus; Diabetic Peripheral Neuropathy; Cognitive Impairment; Quality of Life; Diabetic Peripheral Neuropathic Pain

Summary: this study was set out 1) evaluate the impact of diabetic peripheral neuropathy (dpn) and dpn-p (diabetic peripheral neuropathic pain) on the overall quality of life (qol) in elderly with diabetic mellitus (dm) and 2) evaluate the association between cognition impairments and dm in the elderly, and the contributions of dpn and/or dpn-p


Eligibility criteria:
inclusion criteria: * aged 50 or above * diagnosis of diabetes mellitus (type 1 or type 2) exclusion criteria: * major psychiatric conditions * recent cardiovascular events within the last six months * blindness radiculopathy * spinal cord injury, multiple sclerosis * carpal tunnel syndrome * trigeminal neuralgia * subjects who were incompetent in giving written consent
myocarditis registry for children and adolescents - mykke

Conditions: Myocarditis

Summary: mykke is a prospective multi-center registry for children and adolescents with myocarditis. the aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial disease.

mykke is a long-term prospective registry providing a core platform for clinical research studies, which can be attached in a modular fashion. after a six-month pilot phase including 8 centers, the basic registry was opened in june 2014 to all hospitals in germany treating patients with paediatric heart disease. while the scientific lead is with two study coordinators and a study group consisting of principal investigators from the collaborating centres ("mykke investigators"), mykke is hosted and technically administered by the competence network for congenital heart defects, which was initiated in 2003 by the federal ministry of education and research of the german government and is now part of the german center for cardiovascular research (dzhk). ethical approval was first obtained at the initiating centre (deutsches herzzentrum berlin) and subsequently confirmed by local authorities of all collaborating centres. the treating physicians enter basic data from patients enrolled at the study site via an online web interface to a central study database. for each patient, a specific patient identification number (pid) is generated based on name, first name and date of birth in order to store data in a pseudonymized fashion. as the pids are generated by a specific algorithm, data from the same patient are always linked to the same dataset even when data from different visits are entered by different institutions. the web interface provides two different forms for each patient. the first form ("general sheet") is filled-in only at first presentation and consists of 12 items regarding disease and patient history, and initial symptoms of the disease. the second type of sheet ("current visit") can be generated once for each new patient visit and includes 52 items on characteristics of the current visit, current symptoms, diagnostic tests performed, confidence of the treating physician in the diagnosis on a subjective scale, left-ventricular function, therapy, complications, and follow-up care provider after discharge. items primarily require yes/no responses via ticking respective boxes, allowing for completing each data sheet in \<5 minutes when all data are available.

Eligibility criteria:
inclusion criteria: * admission or referral diagnosis of myocarditis * age \<18 years * written informed consent of the parents or legal guardians exclusion criteria: * unwillingness to give consent

Keywords: myocarditis children adolescents registry multi-center pediatric heart failure inflammatory heart disease inflammatory cardiomyopathy
vns therapy automatic magnet mode outcomes study in epilepsy patients exhibiting ictal tachycardia (e-37)

Conditions: Epilepsy

Summary: obtain baseline clinical outcome data (stage 1) upon which to base a subsequent study (stage 2) of the model 106 vns implantable pulse generator

prospective, observational, un-blinded, multi-site study designed to collect data on patients implanted with a model 106 vns therapy system from baseline through an emu stay of up to 5 days, and 6-month follow-up. after the 6-month follow-up, patients will continue follow-up for safety for approximately two years or until final regulatory approval of the product.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of medically refractory epilepsy with partial onset seizures suitable for implantation with the vns therapy system. * patients willing to undergo an emu evaluation for a period of at least three days with activation of the amm feature during that time. * patients must be at least 12 years old. * patients must be in good general health and ambulatory. * patient or guardian must be willing and able to complete informed consent/assent. exclusion criteria: * patients have had a bilateral or left cervical vagotomy. * patients currently using, or are expected to use, short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy. * a vns therapy system implant would (in the investigator's judgment) pose an unacceptable surgical or medical risk for the patient. * patients expected to require full body magnetic resonance imaging (mri). * patients have a history of implantation of the vns therapy. * patients with an iq known or estimated to be \< 70, history of depression requiring hospitalization, or suicidality as defined by dsm iv-tr that in the investigator's judgment would pose an unacceptable risk for the patient or prevent the patient's successful completion of the study. * patients with a history of status epilepticus within 1 year of study enrollment. * patients with known clinically meaningful cardiovascular arrhythmias as well as patients with clinically meaningful cardiovascular arrhythmias determined by a 24-hour holter recording obtained during the baseline period. * patients dependent on alcohol or narcotic drugs as defined by dsm iv-tr within the past 2 years. * patients with a history of psychogenic non-epileptic seizures. * women who are pregnant. women of childbearing age must take a pregnancy test and agree to use an approved method of contraception during the study. * patients currently enrolled in another investigational study.

Keywords: automatic magnet mode (amm) vagus nerve stimulation (vns)
a study of incb050465 in participants with autoimmune hemolytic anemia

Conditions: Autoimmune Hemolytic Anemia

Summary: the purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (aiha) who have decreased hemoglobin and evidence of ongoing hemolysis that requires treatment intervention.


Eligibility criteria:
inclusion criteria: * diagnosis of aiha based on the presence of hemolytic anemia and serological evidence of anti-erythrocyte antibodies, detectable by the direct antiglobulin test. * participants who have disease progression after treatment with standard therapies that are known to confer clinical benefit, or who are intolerant to treatment, or who refuse standard treatment. there is no limit to the number of prior treatment regimens. * hemoglobin 7 to 10 g/dl. * no evidence of a lymphoproliferative malignancy or other autoimmune-related underlying conditions. * eastern cooperative oncology group performance status of 0 to 2. * willingness to avoid pregnancy or fathering children. exclusion criteria: * pregnant or breastfeeding women. * concurrent conditions and history of other protocol-specified diseases. * anc \< 1.5 × 10\^9/l. * platelet count \< 100 × 10\^9/l. * severely impaired liver function. * impaired renal function with estimated creatinine clearance less than 45 ml/min. * anti-phospholipid antibodies positive or elevated anti-streptolysin antibodies. * positive serology test results for hepatitis b surface antigen or core antibody, or hepatitis c virus antibody with detectable rna at screening, consistent with active or chronic infection. * known hiv infection or positivity on immunoassay. * history or presence of an abnormal ecg that, in the investigator's opinion, is clinically meaningful. * known hypersensitivity or severe reaction to parsaclisib or its excipients.

Keywords: autoimmune hemolytic anemia phosphatidylinositol 3-kinase (pi3k) inhibitor
study of benralizumab (khk4563) in patients with eosinophilic chronic rhinosinusitis

Conditions: Eosinophilic Chronic Rhinosinusitis

Summary: the objective of this study is to evaluate the efficacy and safety of sc administrations of benralizumab or placebo in the subjects with eosinophilic chronic rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. the pharmacokinetics and immunogenicity will be assessed secondarily.

screening period (maximum 4 weeks) , randomized treatment period (24 weeks)

Eligibility criteria:
inclusion criteria: * patients 20 years to 75 years of age * eosinophilic chronic rhinosinusitis with a total score of ≥ 11 according to the diagnosis of eosinophilic chronic rhinosinusitis at enrollment * a minimum bilateral nasal polyp score of 3 out of the maximum score of 8 (with a score of at least 1 out of the maximum score of 4 for each nostril) at screening and at enrollment * weight of ≥ 40 kg at screening exclusion criteria: * a sino-nasal outcome test-22 (snot-22) score of \< 7 at enrollment * any nasal surgery (including polypectomy) within 1 year prior to the date of consent * hospitalization for ≥ 24 hours for treatment of asthma exacerbation, within 12 weeks prior to the date of consent * exposure to any commercially available (e.g., omalizumab) or investigational biologic agent within 16 weeks or 5 half-lives prior to enrollment, whichever is longer * use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (except spraying) within 4 weeks prior to enrollment or planned use of such medications during the double-blind period * prior treatment with benralizumab
self transcranial direct current stimulation for pain in older adults with knee osteoarthritis

Conditions: Knee Osteoarthritis; Chronic Pain

Summary: the purpose of this study is to determine the feasibility and preliminary efficacy of two weeks of self transcranial direct current stimulation (tdcs) for pain in older patients with knee osteoarthritis (oa).


Eligibility criteria:
inclusion criteria: * have self-reported unilateral or bilateral knee oa pain, according to american college of rheumatology criteria * have had knee oa pain in the past 3 months with an average of at least 3 on a 10 cm visual analog scale (vas) for pain * can speak and read english * have a device with internet access that can be used for secure video conferencing for real-time remote supervision * have access to a distraction-free, well lit, clean environment with a safe area to store the device and device kit * have no plan to change medication regimens for pain throughout the trial * are able to travel to the coordinating center * are willing and able to provide written informed consent prior to enrollment. exclusion criteria: * previous prosthetic knee replacement or non-arthroscopic surgery to the affected knee * history of brain surgery, tumor, seizure, stroke, or intracranial metal implantation * systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia * uncontrolled hypertension (i.e., systolic blood pressure/ diastolic blood pressure ≥ 150/95 mm hg) * heart failure * history of acute myocardial infarction * peripheral neuropathy * alcohol/substance abuse * cognitive impairment (i.e., mini-mental status exam score ≤ 23) * pregnancy or lactation * hospitalization within the preceding year for psychiatric illness

Keywords: knee osteoarthritis chronic pain osteoarthritis transcranial direct current stimulation tdcs
oslo antioxidant study

Conditions: Cardiovascular Disease

Summary: the primary objective of this study is to test whether increasing the total intake of antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative damage, and improves biomarkers for oxidative stress. the secondary objectives is to test whether this strategy improves other cardiovascular risk markers including platelet function, lipid levels, inflammation, and markers of endothelial damage.

in this study men smoking 5 or more cigarettes daily will be invited to participate. we will only include individuals with high cardiovascular risk (men rather than women, smokers rather than nonsmokers, middle-aged to elderly rather than young individuals), in order to recruit people with presumed high oxidative stress who might be most likely to show an effect and benefit from our intervention. at the time of inclusion, participants will be randomized to three groups; control group, kiwi group or phytochemical group. the kiwi group will consume three kiwis a day, whereas the phytochemical group will consume an array of antioxidant-rich food stuffs. the intervention period is eight weeks. blood samples will be collected before and after the intervention period.

Eligibility criteria:
inclusion criteria: * men aged 45-75 years * daily smoker of a minimum of 5 cigarettes a day * bmi \<35 kg/m2 (because of difficulties that may be experienced by morbidly obese individuals in following the diet) * stable weight range of 4 kg or less during the previous 12 weeks exclusion criteria: * any symptomatic cvd (myocardial infarction, angina pectoris, cabg, pci, chf, nyha class iii-iv) * diabetes type i or type ii taking drugs for diabetes * following a vegetarian diet or near-vegetarian diet currently * allergy to nuts, kiwi fruits, chocolate, strawberries or tomatoes * clinical disorders including gastrointestinal disease impairing compliance with dietary recommendations * history of serious or unstable medical or psychiatric disorder * current use of or need of lipid lowering drug treatment, aspirin or non-steroidal anti-inflammatory drugs (nsaid), according to assessment of the primary clinical investigator. any "over the counter" headache/ pain or cold remedies taken during the study must not contain aspirin or aspirin like drugs such as ibuprofen. these are classed as and will interfere with platelet function, making them unresponsive for a period of 10-14 days. paracetamol, however, can be taken as an alternative if required * history of alcohol/or drug abuse * participation in a drug trial during the previous 30 days * use of drugs (xenical, reductil), nutritional supplements or herbs for weight loss within the 4 weeks prior to visit 2 or participation in an active weight reduction program * use of single vitamin or other antioxidants (must be stopped 4 weeks prior to visit 2) * individuals judged by the clinical investigator to be unable to follow instructions and procedures of the study.

Keywords: antioxidants phytochemicals oxidative stress inflammation endothelial function